Procedure for Submitting
This section provides guidance for the submission and timeline of the ACIRB process. ACIRB procedures for submitting are also described in an instructional video. The principal investigator (i.e., student, faculty/staff, or external investigator who plans, leads, manages, and conducts a project) must comply with the following procedures by completing the appropriate ACIRB application form (Step Four) and submitting one copy of the fully signed, original application with all supporting documents (e.g., recruitment materials, data collection materials, consent forms, documentation of institutional cooperation, certificate of humans subjects protection training, etc.) electronically to ACIRB@allencollege.edu. Forms submitted by student PIs must also include the contact information and signature of his/her supervising faculty member.
IRB APPROVAL FROM OTHER INSTITUTIONS: The PI must determine if there is an IRB associated with the institution where the project will take place and submit an application for review to that IRB. For example, projects conducted at Allen Hospital need to be reviewed by the ACIRB. The IRB associated with the study setting must provide documentation stating the project has been approved or the project does not require review. In the absence of an IRB associated with the study/project setting, the letter of cooperation (see STEP FIVE below) must state that the participating institution does not have an IRB.
Permission to access private records such as student, medical, or employment records, and so on that are protected by FERPA, HIPAA, or other confidentiality policies, must be obtained from the holders of those records. The PI must obtain permission and provide documentation to the ACIRB from the institution(s) as required by their policies. Please note that ACIRB approval in no way implies or guarantees that permission from these other entities will be granted.
Complete human subjects research protections training. Allen College requires all PIs and key personnel whose projects or studies involve human participants to undergo training in the protection of human subjects. The ACIRB recommends training provided by the Collaborative Institutional Training Initiative (CITI) Program. The ACIRB will also accept National Institutes of Health (NIH) Protecting Human Research Participants Training. For instructions on required training, go to the ACIRB Human Subjects Protections webpage.
Complete the appropriate ACIRB application for human subjects review. Three applications are available on the Forms and Templates webpage:
- ACIRB Review Form: This form should be completed for projects that meet the definition of research and qualify for expedited or full review. If the PI anticipates the project will need full board ACIRB review, all materials must be submitted two full weeks (fourteen calendar days) in advance of the next scheduled ACIRB meeting. Please refer to the ACIRB website for the meeting schedule.
- ACIRB Exempt Review Form: This application may be used in place of the ACIRB Review Form for projects or studies that qualify for exempt review. (Note that the AICRB Review Form CAN be used for exempt projects.) The ACIRB makes the final decision about the appropriate level of review. If the ACIRB Exempt Review Form is filled out but the ACIRB determines that expedited or full review is needed, the PI must complete the ACIRB Review Form prior to the project being reviewed. To assist PIs in making a decision about whether to fill out the ACIRB Review Form or the ACIRB Exempt Review Form, contact ACIRB@AllenCollege.edu.
- ACIRB EBP/QI Review Form: This form should be completed by any student conducting an evidence-based practice or quality improvement project. The ACIRB makes the final decision about the appropriated level of review, so if it is determined that the project requires a higher level of review, the student may be asked to complete the ACIRB Exempt Review Form or ACIRB Review Form. For assistance determining if the ACIRB EBP/QI Form is appropriate, contact ACIRB@AllenCollege.edu.
Include all supporting documents with the appropriate review form. All PIs are required to submit the following:
- Documentation of approval from the IRB affiliated with the project setting if conducted outside of Allen Health System. Allen College students doing projects in University of Iowa Hospitals and Clinics settings will submit a signed, approved Form 3 in lieu of UIHC IRB documentation. These students should refer to Information for Students Who Will be Implementing EBP/QI Projectos at University of Iowa Hospitals and Clinics.
- Documentation of cooperation from the participating project setting: For guidance in preparing this documentation, refer to the ACIRB template for documenting institutional cooperation, located on the Forms and Templates webpage. PIs are encouraged to share the template with the authorized representative who will prepare the documentation of institutional cooperation.
- Allen College students must submit the approved project proposal (i.e. the proposal paper approved by the faculty advisor or course instructor).
Applications for review of research should include a completed ACIRB Application Checklist to verity that all items have been included in the submission. The ACIRB Application Checklist can be accessed on the Forms and Templates webpage. Students submitting applications for review of EBP/QI projects do not need to complete this checklist.
When the documentation from steps one through six has been gathered, name each file using the following format:
For example, suppose that Jane Doe submits an application for review of her project on December 1, 2014. The names of Jane's files should include her last name, the name of the specific document being submitted, and the date Jane is submitting the files. Here are some examples of documents Jane would submit, named according to the ACIRB format:
Doe-ACIRB Review Form-12-01-14
Doe-Human Subjects Protections Certificate-12-01-14
All blank pages should be omitted from electronic files. All documents should be submitted as attachments to a single email message sent to ACIRB@allencollege.edu. Exception: The person authorized to provide documentation of institutional cooperation can CC the ACIRB when providing the PI with email documentation of institutional cooperation.
At the conclusion of the project, all PIs are required to complete the ACIRB Project Completion Form and submit to the ACIRB at: ACIRB@allencollege.edu.
If the project is not concluded within 365 days from the initial approval date, the ACIRB Project Continuation Form must be completed and submitted 30 days prior to the one year anniversary of the initial approval date and submitted to: ACIRB@allencollege.edu.
Additional Information for PIs and Faculty Advisors:
- The ACIRB is responsible for making the final decision on level of review (e.g. exempt, expedited, or full review).
- The ACIRB reserves the right to request further information or to ask questions of the PI regarding information that was submitted. Applications that need corrections or revisions will be returned to the PI from the ACIRB chair within 7 business days from the initial submission and will be reviewed after resubmission at a future meeting. Applications that are not resubmitted within 90 days of original notification will be void.
- Student PIs are encouraged to carbon copy (CC) the faculty advisor on all electronic communication with the ACIRB and to work closely with the faculty advisor during the review process.
- Faculty advisors are required to CC the principal investigator on any submissions made to the ACIRB on behalf of the PI.